Evaluation of the Electronic Clinical Dementia Rating for Dementia Screening.

Importance: The Clinical Dementia Rating (CDR) is a well-validated instrument widely used to detect and stage dementia due to Alzheimer disease. The digital Electronic Clinical Dementia Rating (eCDR) can be remotely self-administered and automatically scored, with potential to facilitate efficient dementia screening and staging. Objective: To evaluate the association of the eCDR with the CDR and other in-clinic assessments for screening older adults for cognitive impairment. Design, Setting, and Participants: This multisite, cross-sectional study used baseline data from a longitudinal, observational study from 2020 to 2023, including up to 3 years of follow-up. Participants were enrolled from 3 Alzheimer Disease Research Centers and the Brain Health Registry. Participants (aged ≥55 years, with a study partner, and no acute or unstable major medical conditions) were recruited during in-clinic visits or by automated emails. Exposures: Participants completed the Uniform Data Set Version 3 (UDS; including the CDR) in supervised clinical research settings, and then completed the eCDR remotely, online and unsupervised, using their own device. Main Outcomes and Measures: The primary outcomes were eCDR scores (item; categorical box and global; continuous box and global), CDR scores (item; categorical box and global), and UDS assessment scores. Associations were evaluated using linear and logistic regressions. Results: A total of 3565 participants were contacted, and 288 were enrolled. Among 173 participants with item-level data (mean [SD] age, 70.84 [7.65] years; 76 women [43.9%]), eCDR to CDR concordance was 90% or higher for 33 items (63%) and 70% to 89% for 13 items (25%). Box (domain) level concordance ranged from 80% (memory) to 99% (personal care). The global score concordance rate was 81%. κ statistics were fair to moderate. Among 206 participants with box and global scores (mean [SD] age, 71.34 [7.68] years; 95 women [46.1%]), eCDR continuous global score was associated with CDR global (categorical) score with an area under the receiver operating characteristic curve of 0.79 (95% CI, 0.70-0.87). Correlations between eCDR and in-clinic UDS assessments were similar to those between CDR sum of box scores and the same in-clinic assessments. Conclusions and Relevance: These findings suggest that the eCDR is valid and has potential use for screening and assessment of older adults for cognitive and functional decline related to Alzheimer disease. Instrument optimization and validation in diverse cohorts in remote settings are crucial for evaluating scalability and eCDR utility in clinical research, trials, and health care settings.

Development and implementation of an electronic Clinical Dementia Rating and Financial Capacity Instrument-Short Form.

Introduction: To address the need for remote assessments of cognitive decline and dementia, we developed and administered electronic versions of the Clinical Dementia Rating (CDR®) and the Financial Capacity Instrument-Short Form (FCI-SF) (F-CAP®), called the eCDR and eFCI, respectively. Methods: The CDR and FCI-SF were adapted for remote, unsupervised, online use based on item response analysis of the standard instruments. Participants completed the eCDR and eFCI first in clinic, and then at home within 2 weeks. Results: Of the 243 enrolled participants, 179 (73%) cognitively unimpaired (CU), 50 (21%) with mild cognitive impairment (MCI) or dementia, and 14 (6%) with an unknown diagnosis, 84% and 85% of them successfully completed the eCDR and eFCI, respectively, at home. Discussion: These results show initial feasibility in developing and administering online instruments to remotely assess and monitor cognitive decline along the CU to MCI/very mild dementia continuum. Validation is an important next step.

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.

INTRODUCTION: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. METHODS: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. RESULTS: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. CONCLUSIONS: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.

INTRODUCTION: The updated common rule, for human subjects research, requires that consents "begin with a 'concise and focused' presentation of the key information that will most likely help someone make a decision about whether to participate in a study" (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613-615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377-381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant's race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529-534.). METHODS: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. RESULTS: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. CONCLUSIONS: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

Adapting an Early Palliative Care Intervention to Family Caregivers of Persons With Advanced Cancer in the Rural Deep South: A Qualitative Formative Evaluation.

CONTEXT: There is a scarcity of early palliative care interventions to support family caregivers of persons with advanced cancer living in the rural Southern U.S. OBJECTIVE: The objective of this study was to adapt the content, format, and delivery of a six session, palliative care, telehealth intervention with monthly follow-up for rural family caregivers to enhance their own self-care and caregiving skills. METHODS: Qualitative formative evaluation consisting of one-on-one, semistructured interviews with rural-dwelling persons with metastatic cancer (n = 18), their primary family caregiver (n = 20), and lay patient navigators (n = 26) were conducted to elicit feedback on a family caregiver intervention outline based on published evidence-based interventions. Transcribed interviews were analyzed using a thematic analysis approach. Coinvestigators reviewed and refined preliminary themes. RESULTS: Participants recommended that intervention topical content be flexible and has an adaptable format based on continuous needs assessment. Sessions should be 20 minutes long at minimum, and additional sessions should be offered if requested. Faith and spirituality is essential to address but should not be an overarching intervention theme. Content needs to be communicated in simple language. Intervention delivery via telephone is acceptable, but face-to-face contact is desired to establish relationships. Other Internet-based technologies (e.g., video-conferencing) could be helpful, but many rural dwellers may not be technology savvy or have Internet access. Most lay navigators believed they could lead the intervention with additional training, protocols for professional referral, and supervision by specialty-trained palliative care clinicians. CONCLUSIONS: A potentially scalable palliative care intervention is being adapted for family caregivers of rural-dwelling persons with advanced cancer and will undergo piloting in a small-scale randomized controlled trial.

The Patient Care Connect Program: Transforming Health Care Through Lay Navigation.

The Patient Care Connect Program (PCCP) is a lay patient navigation program, implemented by the University of Alabama at Birmingham Health System Cancer Community Network. The PCCP's goal is to provide better health and health care, as well as to lower overall expenditures. The program focuses on enhancing the health of patients, with emphasis on patient empowerment and promoting proactive participation in health care. Navigator training emphasizes palliative care principles and includes development of skills to facilitate advance care planning conversations. Lay navigators are integrated into the health care team, with the support of a nurse supervisor, physician medical director, and administrative champion. The intervention focuses on patients with high needs to reach those with the greatest potential for benefit from supportive services. Navigator activities are guided by frequent distress assessments, which help to identify patient concerns across multiple domains, triage patients to appropriate resources, and ultimately overcome barriers to health care. In this article, we describe the PCCP's development, infrastructure, selection and training of lay navigators, and program operations.

Guiding Lay Navigation in Geriatric Patients With Cancer Using a Distress Assessment Tool.

BACKGROUND: There is growing interest in psychosocial care and evaluating distress in patients with cancer. As of 2015, the Commission on Cancer requires cancer centers to screen patients for distress, but the optimal approach to implementation remains unclear. METHODS: We assessed the feasibility and impact of using distress assessments to frame lay navigator interactions with geriatric patients with cancer who were enrolled in navigation between January 1, 2014, and December 31, 2014. RESULTS: Of the 5,121 patients enrolled in our lay patient navigation program, 4,520 (88%) completed at least one assessment using a standardized distress tool (DT). Navigators used the tool to structure both formal and informal distress assessments. Of all patients, 24% reported distress scores of 4 or greater and 5.5% reported distress scores of 8 or greater. The most common sources of distress at initial assessment were pain, balance/mobility difficulties, and fatigue. Minority patients reported similar sources of distress as the overall program population, with increased relative distress related to logistical issues, such as transportation and financial/insurance questions. Patients were more likely to ask for help with questions about insurance/financial needs (79%), transportation (76%), and knowledge deficits about diet/nutrition (76%) and diagnosis (66%) when these items contributed to distress. CONCLUSIONS: Lay navigators were able to routinely screen for patient distress at a high degree of penetration using a structured distress assessment.